BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3912761 · Received July 3, 2014

    Report

    Report Number
    3007042319-2014-00692
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    February 19, 2014
    Report Date
    June 5, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. THIS EVENT RELATES TO THE FSCA Z-1607-2014 ISSUED BY HEARTWARE, INC. FOR THIS MATTER. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00180, 3007042319-2014-00690, 3007042319-2014-00691, AND 3007042319-2014-00692) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF CONFORMANCE MATERIAL RECORD CONFIRMED THAT THE BATTERY MET ALL REQUIREMENTS FOR RELEASE. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL PAIR. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPEN TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00180, 3007042319-2014-00690, 3007042319-2014-00691, AND 3007042319-2014-00692) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND FOUR MONTHS POST HEARTWARE LVAD IMPLANTATION, THE PATIENT REPORTED A VAD STOP ALARM WITH HIS CONTROLLER WHILE CHANGING BATTERIES. THE PUMP IMMEDIATELY STARTED AFTER RECONNECTING TO A BATTERY. HEARTWARE FIELD ENGINEERS RECOMMENDED EXCHANGE OF BATTERIES AND THE CONTROLLER. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. PRELIMINARY LOG FILE ANALYSIS INDICATES A PUMP STOP (CONTROLLER POWER-UP/PUMP MOTOR START) THE DAY PRIOR TO AND ON THE DAY OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389585 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - CONTROLLER| (B)(4) - BATTERY| (B)(4) - BATTERY